A structured approach to quality management systems isn't a new concept for organizations in pharma, life sciences, or medical device industries. ISO 9000/9001, one of the most universally acknowledged sets of standards for quality management systems, was first published in 1987. What's changed since the 1980s is the role of software in a global quality-focused organization.
As companies face increasing compliance and industry pressures, cloud-based software is playing an increasingly important role in operationalizing quality management systems.
The global market for quality management software (QMS) is projected to reach a value of $13.94 billion by 2025, according to a recent study by Grand View Research. The same survey found that cloud adoption is driving the industry, particularly among small and mid-sized enterprises (SME) who are deploying QMS for the first time.
The right QMS can offer a host of benefits to your organization, which include more consistent quality practices, improved efficiency, reduced waste, and higher customer satisfaction. However, if you're asking "what's the best quality management software?" you aren't asking the right question.
6 of the Best Quality Management Software Platforms Reviewed
A more valuable question is "what's the best quality management software for my company's requirements?" There is no shortage of options on the marketplace, and your organization's size, stage, and focus can significantly impact requirements for a QMS. The right cloud-based tool for a life sciences startup is likely very different than the best solution for a well-established pharmaceutical organization with a broad portfolio of approved drugs.
A search for “quality management software” on G2 Crowd reveals 107 options in this space, which vary from complex and rigid platforms to lighter weight, cloud-based solutions. To help ease your selection process we've curated real user reviews of some of the best-known options and analysis of which types of companies can benefit from these solutions.
It Works Well For: Companies with 200+ employees.
MasterControl is a well-known quality management software designed to serve as a comprehensive QMS system throughout the entire product lifecycle for bringing products to market and increasing operational efficiency. MasterControl has currently been deployed at over 1,000 customers in 30 countries worldwide and five major regulatory agencies.
MasterControl can require an extensive amount of specialized IT support for successful implementation, or full-time quality management resources dedicated exclusively to the platform. One G2 reviewer noted MasterControl is “Difficult to use. The system takes a long time to learn….It is difficult to tell what you are supposed to do in order to sign off and hard to actually find the document that needs to be reviewed.”
Other reviews note the relatively high cost is a barrier to adoption at SME organizations with a limited QMS budget, and the wait times for configuration can be lengthy. Testimonials of MasterControl praise the system's interoperability across total quality management, including one user who wrote "What I liked best overall was the connectivity between elements of the system. Each item, from nonconformances to CAPAs, to internal audits, was linked effectively."
MasterControl is a robust quality management option for large organizations or mid-market companies with extensive personnel resources to dedicate to providing platform support and configuration. According to iDataLabs, the majority of adopting companies have at least 200 employees and $10-50 million in annual revenue.
Related Reading: 13 Bottom Line-Boosting Benefits of a Quality Management System
It Works Well For: Companies with 1,000+ employees.
Trackwise Enterprise Quality Management Software (EQMS) by Sparta Systems is a leading solution designed to offer extensive flexibility and configuration features to large organizations in a variety of highly regulated industries. With enterprise-wide visibility and tracking features, Trackwise states the benefits of adoption include optimized quality, greater compliance, and reduced risk.
User reviews of Trackwise report the system complexity can be a barrier to simplified workflows. Online feedback states the “queries and reports are not that easy,” and that it can be “difficult at times to track [processes] back to the beginning.” Due to the high cost and steep configuration requirements, one reviewer noted they were “locked in” to using Trackwise.
Online positive reviews praise Trackwise's simple electronic digital signatures and fast updates to reflect emerging regulatory requirements. One user praised "release cycles, product, customer support, documentation, [and] communication." Due to the system complexity and the number of resources needed to manage this EQMS effectively, Trackwise is generally best suited for enterprise users with 1,000 or more employees.
It Works Well For: Packaging for mid-large companies with approved products.
GlobalVision is a cloud-based, software-as-a-service (SaaS) solution specializing in packaging and labeling for highly regulated industries. It is a quality control platform designed to help businesses with approved products eliminate packaging errors with workflows for error discovery and approval before printing labels.
“The software can be slow, depending on the size of the files we are using,” writes one reviewer on G2Crowd. “There is also a somewhat steep learning curve, but overall the software is very user-intuitive.” Other reviewers note that adding new documents for review sometimes “takes longer and is more complicated than warranted,” and can slow approval processes unnecessarily.
Positive reviews of GlobalVision praise the organization's commitment to creating products that are both robust and user-friendly and note the company is highly responsive to suggestions for improvement. This product is best suited for organizations with approved products in the marketplace, including midsized and large companies. You may benefit from GlobalVision if you have an existing solution for total quality management, and need an additional solution specifically to manage packaging and label processes.
It Works Well For: Manufacturing organizations not in highly regulated industries.
1Factory is a comprehensive quality management solution designed for total quality control across the supply chain at manufacturing organizations. The solution isn't necessarily tailored to the needs of highly regulated organizations in pharma, medical devices, or life sciences. Instead, it's broadly designed for organizations who need analytics and quality management capabilities for complex manufacturing processes with features for factory defect monitoring, nonconformances, and process capability.
Online reviews of the software are mainly positive from users at manufacturing organizations which specialize in products such as optics and precision machining. One user notes a wish to "add more report formats and make reports configurable," while another reviewer notes there can be a steep user learning curve.
“Since implementing 1Factory on our shop floor we have seen a noticeable improvement with less non-conformance found during final inspection,” says another reviewer who works at a computer numerical control (CNC) machining manufacturer. The same user reports the overall manufacturing flow has been improved and they have experienced a lift in customer satisfaction.
1Factory is best-suited for manufacturing organizations with a need to implement greater quality control throughout production processes with features to define product specifications, tolerances, and zones in precision machining and related fields.
It Works Well For: Companies with a need for mobile form submission.
SafetyCulture is software for automating mobile form submission instead of a comprehensive quality management solution. Its purpose is to simplify safety inspections and audits with a mobile platform for form submission, workflow automation, and analytics. SafetyCulture offers built-in integration with other platforms, such as SharePoint.
Online user reviews of SafetyCulture from adopters in industries such as construction, education, and consumer packaged goods sway primarily positive. One user noted on Software Advice that "extracting the data collected by the app can be difficult but not impossible." Another user at a plumbing company wrote that he would prefer deeper integration with other solutions for job management.
Satisfied users of SafetyCulture praise the solution’s features for quickly creating quality inspection lists which appear very professional since they can be branded with company logos. “I can use iAuditor from either my phone, tablet or laptop, depending on what I have on-hand while on-site,” writes another user at a construction company. “I can create various types of question/review items, (including) buttons, drop downs, [and] multi-line text fields.”
SafetyCulture is a flexible platform to conduct and submit audits and reviews which can be used by companies in pharma, life sciences, medical devices, construction, manufacturing, and countless other industries. It is not necessarily designed to act as a comprehensive quality management solution for organizations of any size in highly regulated industries with features for all cGMP, though it can be a valuable point solution.
It Works Well For: Life Science startups and scale-ups.
Qualio is a comprehensive, cloud-based quality management software for highly regulated organizations in a variety of industries, including pharma, life sciences, medical devices, and manufacturing. Key features include document management, collaboration, employee training, and audit trails. Benefits include workflow automation, improved compliance, and flexible scalability.
Qualio has an average of 5/5 star review ratings from verified adopters on SoftwareAdvice. One user at a diagnostics firm states "Qualio is easy to use, and hard to do wrong" with user-friendly interfaces and automatic accommodation for FDA requirements. "We pull multiple reports from Qualio for our compliance audits, and they are never questioned," states another user at a MedTech firm. "Qualio support listens to both feature requests and existing changes that are needed and addresses all promptly."
Qualio is best-suited for small-to-midsized manufacturing organizations in highly regulated industries, including startups and scale-ups in pharma, medical devices, or life sciences fields. It offers straightforward configuration and flexible scalability to accommodate the evolving needs of organizations throughout the research, development, and product approval phases.
Getting The Best Features for Your Company
There is no shortage of options when it comes to quality management software (QMS). The definition of “the best” solution can vary significantly depending on who you ask. Ultimately, the determining factor of which software is the best can depend on your organization’s size, stage, and requirements.
A QMS designed for a sizeable precision-machining firm isn't going to meet the pricing or compliance requirements of a life sciences startup. Research how the leading QMS excel to find the one best suited for your use cases and verify the quality of experience by reading online user reviews.
Wondering if Qualio is right for you? For more insight into the platform's features for total quality management, click here for a demo.